FDA is taking steps to help further accelerate the development of novel drug and biological products for rare diseases.
FDA has approved Bosulif (bosutinib) for pediatric patients ages one year and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed or resistant or intolerant (R/I) to prior therapy.
FDA has cleared the B·R·A·H·M·S CgA II Kryptor immunoassay to assess tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.
FDA has granted Fast Track designation to Mythic’s investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer with cMET overexpression.
Pierre Fabre Laboratories and Vernalis, a fully owned subsidiary of HitGen Inc., established a long-term partnership to identify pre-clinical candidates against oncology targets.
Mission Bio has developed a single-cell measurable residual disease assay that aims to advance personalized healthcare for patients with blood cancer.
FDA has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia), in adults with anemia.
FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for Keytruda (pembrolizumab) in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk, locally advanced cervical cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Keytruda (pembrolizumab) for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicine Agency has adopted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with doxorubicin, vinblastine, and dacarbazine—or AVD—in adult patients with previously untreated CD30+ stage 3 Hodgkin lymphoma.
